Communicating and Negotiating with FDA: Medical Devices
By External Provider
About this course
This course trains regulatory professionals in how to communicate strategically and effectively with the U.S. Food and Drug Administration (FDA), especially in the context of medical device development. While the FDA is not a negotiator in the conventional sense, interactions with the Agency require scientific framing, structured reasoning, and ethical persuasion. Through real-world scenarios, document analysis, and structured assignments, learners will develop the judgment needed to prepare for pre-submission meetings, frame effective regulatory questions, respond to inspections or enforcement actions, and escalate disagreements professionally and appropriately. The course emphasizes the FDA's public health mission, legal boundaries, and internal review logic, focusing on what can be influenced, what cannot, and how to operate effectively within that structure.
What you will learn
- Frame FDA communications using regulatory logic, scientific clarity, and professional tone.
- Distinguish negotiable from non-negotiable issues in FDA interactions and align strategy accordingly.
- Prepare, execute, and respond to FDA meetings, inspections, and enforcement actions with sound judgment.